Additional nutrition during chemotherapy ahead of surgery in esophageal, GE-junction, stomach, pancreas or rectum cancer for reduction of postoperative complications

Parenteral Nutrition during neoadjuvant chemotherapy for patients with advanced cancer of the GE-junction/esophagus/stomach/pancreas or rectum for reduction of postoperative morbiditiy - PERCOG

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005219-34-DE

Enrollment

150

Registered

2017-03-20

Start date

2017-05-16

Completion date

Unknown

Last updated

2021-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced carcinoma of the GE-junction or esophagus (adenocarcinoma or squamous cell carcinoma), gastric antrum, body or fundus or carcinoma of the pancreas or carcinoma of the rectum requiring neoadjuvant treatment ahead of surgery (chemotherapy and/or chmoradiotherapy) MedDRA version: 21.1 Level: PT Classification code 10017758 Term: Gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.1 Level: PT Classifi

Interventions

Trade Name: Nutriflex Omega plus BBRaun Nutriflex Omega special BBraun Nutriflex lipid plus BBraun Clinimix BAXTER Aminomix Fresenius Kabi Pharmaceutical Form: Solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically proven locally advanced carcinoma of GE- junction or Esophagus or Stomach or Pancreas or Rectum Requiring neoadjuvant chemotherapy or radio-(chemo-)therapy ahead of surgery 2. Nutritional Risk Score (NRS) =3 3. Age>18 years 4. ECOG grade 0-2 5. Negative proof of pregnancy for potentially childbearing women. 6. Sufficient bone marrow, liver- and kidney-function according to the attending oncologist´s expert opinion Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: 1. Non-resectable carcinoma of the GE-junction, esophagus, stomach, pancreas or rectum 2. Participation in a different randomized controlled trial potentially interfering with the primary endpoint. 3. Pregnancy or breast feeding. 4. Impairing cardiac disease such as unstabel angina pectoris, unstable coronary heart disease, cardiac failure (NYHA IV), malignant hypertension) or pulmonary disease (COPD stage GOLD IV), representeing a contraindication to neoadjuvant chemotherapy or surgical resection. 5. Insufficient patient compliance.

Design outcomes

Primary

Measure	Time frame
Main Objective: This randomized controlled study aims to improve the general condition during neoadjuvant chemotherapy in order to decrease the postoperative Comprehensive Complication Index on the 30th postoperative day by supplemental parenteral nutrition in patients with non-metastasized locally advanced carcinoma if the GE-junction or esophagus or stomach or pancreas or rectum requiring multimodal treatment (chemotherapy or chemoradiotherapy ahead of surgery);Secondary Objective: Not applicable;Primary end point(s): Comprehensive Complication Index on day 30 after oncologic resection;Timepoint(s) of evaluation of this end point: day 30 after surgical resection	—

Measure

Time frame

Main Objective: This randomized controlled study aims to improve the general condition during neoadjuvant chemotherapy in order to decrease the postoperative Comprehensive Complication Index on the 30th postoperative day by supplemental parenteral nutrition in patients with non-metastasized locally advanced carcinoma if the GE-junction or esophagus or stomach or pancreas or rectum requiring multimodal treatment (chemotherapy or chemoradiotherapy ahead of surgery);Secondary Objective: Not applicable;Primary end point(s): Comprehensive Complication Index on day 30 after oncologic resection;Timepoint(s) of evaluation of this end point: day 30 after surgical resection

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Secondary

Measure	Time frame
Secondary end point(s): 1.) Registration of the complication rate during neoadjuvant chemotherapy according to the Common Terminology Criteria for Adverse Events (CTCAE v4.03). 2.) Registration of the complication rate associated with application of parenteral nutrition according to CTCAE v4.03. 3.) Registration of the total amount of complications and postoperative morbidity within a postoperative period of 30 days according to the Clavien-Dindo classification and CTCAE v4.03. 4.) Registration of Quality of Life according to EORTC QLQ-C30 questionnaire. 5.) Development of body weight and BMI 6.) Length of hospital stay 7.) Length of ICU stay;Timepoint(s) of evaluation of this end point: day 30 after surgical resection	—

Measure

Time frame

Secondary end point(s): 1.) Registration of the complication rate during neoadjuvant chemotherapy according to the Common Terminology Criteria for Adverse Events (CTCAE v4.03). 2.) Registration of the complication rate associated with application of parenteral nutrition according to CTCAE v4.03. 3.) Registration of the total amount of complications and postoperative morbidity within a postoperative period of 30 days according to the Clavien-Dindo classification and CTCAE v4.03. 4.) Registration of Quality of Life according to EORTC QLQ-C30 questionnaire. 5.) Development of body weight and BMI 6.) Length of hospital stay 7.) Length of ICU stay;Timepoint(s) of evaluation of this end point: day 30 after surgical resection

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Countries

Germany

Contacts

Public ContactDepartment of Surgery - PD Dr. Reim

Klinikum Rechts der Isar

daniel.reim@tum.de+498941405019

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026